The Visual Effect of an Investigational Artificial Tear in the Tear Layer.

October 21, 2007 updated by: Southern California College of Optometry at Marshall B. Ketchum University
The purpose of this study is to investigate how the addition of a new artificial tear product when applied to the tear layer affects contrast sensitivity and optical aberrations over time. We will also determine if there are any adverse effects associated with drop instillation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Artificial tears are applied to the eye to treat a variety of eye conditions. These conditions typically are associated with dry eyes and include tear film deficiency due to ocular or systemic disease, lid resurfacing problems, and contact lens wear. The artificial tears are used to alleviate the dry eye symptoms. The administration of an artificial tear to the eye can disrupt the tear layer and this disruption could then result in a decrease in contrast sensitivity.1 - 6

Temporal changes in tear film structure (e.g., drying of the tear layer) can distort the optical wavefront as it passes through the tear layer and subsequently reduce contrast sensitivity.1 Theoretically, any substance applied to the tear layer that alters its structure could affect contrast sensitivity. Previous work in our lab has demonstrated that Refresh Liquigel when applied to the tear layer of non-contact and contact lens wearing subjects can decrease contrast sensitivity.4, 5, 7 In this study, we propose to examine the effects of a new investigational artificial tear on contrast sensitivity and optical aberrations for up to 30 minutes after administration into the tear layer of normal and dry eye subjects. A questionnaire will also be used to determine the opinions of the subjects concerning this new artificial tear.

Study Type

Interventional

Enrollment

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fullerton, California, United States, 92831
        • Southern California College of Optometry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Thirty subjects free from ocular pathology will be chosen. Ten of the subjects will have a normal tear layer, ten will have a mild dry eye, and ten will have a moderate/severe dry eye. All subjects will be over the age of 18. Best corrected visual acuities will be at least 20/25 on a standard Snellen acuity chart at distance.

Exclusion Criteria:

  • Subjects will be excluded from this project if they have, or during the course of the experiment they develop, an allergy to the eye drops used in this project.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Contrast sensitivity and optical aberrations before daily artificial tear use and at 1 and 2 weeks after daily use
Dry eye questionnaire before and at 1 and 2 weeks after artificial tear use
Slit lamp exam before and at 1 and 2 weeks after artificial tear use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern California College of Optometry at Marshall B. Ketchum University

Collaborators

Allergan

Investigators

  • Principal Investigator: William Ridder, OD. PhD, Southern California College of Optometry at Marshall B. Ketchum University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

November 2, 2006

First Submitted That Met QC Criteria

November 2, 2006

First Posted (ESTIMATE)

November 3, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

October 23, 2007

Last Update Submitted That Met QC Criteria

October 21, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCCO2-2233

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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